TruSkin®: Study for Treatment of Chronic Venous Leg Ulcers

NCT02936128 | Terminated Phase 4

• 1 other identifier: Osiris Protocol 352
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to compare the clinical outcomes of TruSkin® and an Active Comparator in patients with chronic venous leg ulcers.

Conditions

Chronic Venous Leg Ulcers

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that achieve a 50% or greater reduction in wound size by 8 weeks

  8 weeks

Secondary Outcomes (6)

• Proportion of patients that achieve complete closure of the index wound by 12 weeks

  12 weeks

• Proportion of patients that achieve a 50% or greater reduction in wound size by 4 weeks

  4 weeks

• Time to initial wound closure

  Up to 84 days

• Number of product applications

  Up to 84 days

• Number of AEs

  Up to 84 days

Study Arms (2)

TruSkin®

EXPERIMENTAL

Cryopreserved skin allograft

Other: TruSkin

Wound Cover

ACTIVE COMPARATOR

Active Comparator for Venous Leg Ulcers

Other: Wound Cover

Interventions

TruSkin OTHER

TruSkin®

Wound Cover OTHER

Wound Cover

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 years and 80 years of age inclusive, as of the date of screening
• An Index Ulcer that is chronic (defined as present for \> 4 weeks, but not present for more than 52 weeks at the Screening Visit)
• Index Ulcer is located on the leg, below the knee
• The Index Ulcer is a Venous Leg Ulcer (VLU) greater than 10 cm2, inclusive, at the Screening Visit
• The longest length and longest width measurements for the Index Ulcer are no less than 1 cm each at the Screening Visit
• The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
• Wound is free of necrotic debris
• Patient has adequate circulation to the foot as documented by Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
• Confirmed diagnosis of venous insufficiency with duplex ultrasonography to demonstrate reflux of ≥ 0.5 seconds in the superficial lower extremity venous system.

You may not qualify if:

• Index Ulcer is of non-venous pathophysiology
• Gangrene is present on any part of the affected limb
• Patient is currently receiving dialysis or planning to go on dialysis
• Patient has a glycated hemoglobin A1c (HbA1c) level of \>12%
• Chronic oral steroid use \>7.5 mg daily for longer than 3 months at the time of screening
• Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
• Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
• Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
• Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
• Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
• Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
• Patient has active malignancy other than non-melanoma skin cancer
• Patient's Index Ulcer has decreased by ≥ 20% during 1-week screening period
• Patient's random blood sugar is \> 450 mg/dl at screening
• Patient is unable to receive compression therapy as a part of standard of care

Sponsors & Collaborators

• Osiris Therapeutics: lead

Study Sites (7)

Unknown Facility

California City, California, United States

Location

Unknown Facility

Florida City, Florida, United States

Location

Unknown Facility

Massachusetts, Massachusetts, United States

Location

Unknown Facility

Michigan, Michigan, United States

Location

Unknown Facility

North Carolina, North Carolina, United States

Location

Unknown Facility

Pennsylvania, Pennsylvania, United States

Location

Unknown Facility

Virginia City, Virginia, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: October 18, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)